Z-1058-2014 Class II Terminated
FDA device recall Z-1058-2014 was initiated by BioHorizons Implant Systems Inc on Dec 10, 2013 and is designated Class II. Reason for recall: The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length. The recall status is terminated (terminated Mar 28, 2014). Affected quantity: 119 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 26, 2014
- Initiation Date
- Dec 10, 2013
- Termination Date
- Mar 28, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 119 units
Product Description
External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 Usage: dental
Reason for Recall
The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length.
Distribution Pattern
Worldwide distribution: US (nationwide) to states of: LA, CA, NC, IL, PA, and NY; and Internationally to: Seoul, Korea; New Delhi, India; Taipei City, Taiwan; and Madrid, Spain.
Code Information
Lot Number 1302762, Exp 31 MAY 2018
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1058-2014
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026